Med-Tech Innovation News spoke to Francois Michelon from ENDRA Life Sciences which has developed a module system that can be incorporated into an ultrasound device to measure liver fat in a bid to make assessments for convenient.
First, tell us about the need to measure liver fat?
A normal healthy liver has 0% fat. Anything over 5%-6% liver fat is of clinical concern, and qualifies as Non-Alcoholic Fatty Liver Disease (NAFLD).
NAFLD can progress asymptomatically to inflammation (Non-Alcoholic Steatohepatitis or NASH), then scarring of the liver (fibrosis) and then liver cell death (cirrhosis) and cancer.
Excess weight and lifestyle is correlated to NAFLD, but you don't have to be overweight to have NAFLD-NASH. If you have a genetic predisposition or have diabetes, or polycystic ovarian syndrome, or HIV, you have a higher likelihood of developing NAFLD.
An estimated 1.8 billion people are globally affected with NAFLD-NASH -- all sexes, races, and ages. In the UK alone NAFLD-NASH estimates range from 25%-35% of the population: that's over 20 million people!
NAFLD has now overtaken Hepatitis as the leading root cause of liver transplants.
Is there any other solution out there which can measure this?
Currently there is no blood test or practical diagnostic tool for NAFLD-NASH.
Magnetic Resonance Imaging (MRI) is very accurate, but slow, the equipment weighs 3+ tons and an MRI machine costs $2.5 million to buy -- so it's not a practical solution to screen over 1 billon people and monitoring them every few months to see how the NAFLD-NASH disease is progressing. Economically MRI is not feasible.
Surgical liver biopsy is also fairly accurate, but it's invasive, painful (a large needle is inserted between your ribs and a core sample of your liver is extracted) and there's the risk of internal bleeding. So, this technique is typically reserved for more advanced diseases like fibrosis or cancer.
So, the world needs a NAFLD-NASH technology that is both diagnostically accurate and practical (safe, cost-effective, easy to use) at the point of patient care.
ENDRA has developed a proprietary technology called Thermo Acoustic Enhanced Ultrasound (TAEUS) which is initially focused on the measurement of fat in the liver to assess and monitor NAFLD and NASH. It costs $50,000 and can be used at the patient point of care.
Tell us about the technology that has gone into this diagnostic?
ENDRA has over 80 intellectual property assets related to TAEUS.
TAEUS is a unique technology that uses short radio frequency (RF) pulses to generate ultrasound signals, enabling clinicians to assess tissue like an MRI, but at 1/50th the cost and at the point of patient care.
TAEUS is different than traditional ultrasound, which uses sound waves into and reflected from the body. Traditional ultrasound cannot quantify fat in the liver at low levels.
TAEUS is intended to enhance the utility of, and work in concert with, the 400,000 cart-based traditional ultrasound systems in use globally today.
Can you tell us what it’s made from and how it works alongside other medical devices?
The TAEUS system is comprised of a box with a computer and software that sits alongside a traditional ultrasound system in a clinicians' examination room. Additionally, there is a handheld TAEUS probe that is used to make the patient NAFLD measurement. The probe is placed on the right side of a patient's ribcage (liver side) and the NAFLD scan only takes a few seconds.
It's a simple system to learn, and clinicians can be trained in as little as 15 minutes.
Where is it available?
TAEUS has received the CE regulatory mark and ENDRA is commercialising the product in the UK and Europe now. In fact, we have a great ENDRA salesperson in the lovely city of Birmingham!
We've also recently announced a wonderful clinical evaluation partnership with Kings College Hospital, London.
Any plans to develop the product further?
Geographically, we are working on our U.S regulatory (FDA) approval, and we've just announced our first hospital collaboration in China.
Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualisation of tissue temperature to guide surgeons during energy-based surgical procedures to treat cancer, pain, and cardiological conditions.
Anything else you’d like to add?
AFLD also affects children. Childhood obesity is a growing problem (and it is something we hear a lot in the UK) and from a health system cost standpoint, early detection will save a lot of resources down the road as NAFLD detected early will lead to a change in the patient care pathway before the disease evolves into something more acute like NASH, Fibrosis, Cirrhosis and HCC (liver cancer).
The late phases of NAFLD are non-reversible and the only treatment is liver transplant.
It's an exciting time to work in healthcare, and ENDRA's small team (of ~30 people) is passionate about developing technology that can improve people's lives.
